September 2014 FDA Recall E-z-gas by Bracco Diagnostic Inc
D-0014-2015 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Bracco Diagnostic Inc on September 18, 2014 for the product E-z-gas. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0014-2015
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
09-18-2014
10-15-2014
58,050 packets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bracco Diagnostic Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-30-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01
Batch or Lot Expiration Information
Lot# F12C01; Exp. 02/15
